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Project Horizon: Hydrogel Injectable Depot System for Next-Generation Long-Acting HIV Prevention and Contraception

Award Number: R33AI142685
ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 02/01/2019
PERIOD OF PERFORMANCE END DATE: 03/31/2026

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Project Horizon: Hydrogel Injectable Depot System for Next-Generation Long-Acting HIV Prevention and Contraception - PROJECT SUMMARY/ABSTRACT There is a need to develop next-generation multipurpose prevention technologies (MPTs) that provide long-acting (LA), simultaneous systemic delivery of products for the prevention of HIV acquisition and unintended pregnancy. We propose to develop a novel silica hydrogel-based LA injectable depot system delivering dolutegravir (DTG), a proven and potent HIV integrase strand-transfer inhibitor (INSTI), and levonorgestrel (LNG), a licensed contraceptive agent. In the first (R61) phase of the project (Specific Aims 1-3), the main objective is to achieve milestones demonstrating feasibility of developing a particle-based hydrogel depot system capable of providing at least 3 months duration for both drugs, shorter tail pharmacokinetic (PK) profiles, and no drug-drug interaction (DDI). In Specific Aim 1, we will conduct iterative formulation development to produce and screen prototype combinations for initial feasibility, which will then be evaluated preclinically in Specific Aim 2 in rat and non-human primate models to determine optimal PK/pharmacodynamics (PD) profiles and characterize safety and DDI, to support selection of a lead MPT formulation. In Specific Aim 3, we will engage with potential end-users in a US region with high HIV incidence to gain a more in-depth understanding of user preferences of product attributes. In the second (R33) phase (Specific Aims 4-6), the main objectives will be to expand product development efforts to characterize the lead formulation and obtain IND-enabling feedback from the FDA in a pre-IND meeting, conduct POC contraceptive efficacy and HIV prophylactic efficacy in animal studies, and define the optimal dosing regimen and target product profile (TPP) based on end-user input. In Specific Aim 4, formulation optimization activities will be performed to improve the harmonized PK profile and duration for each drug and to better meet the product attribute preferences prioritized by end users. Preclinical proof-of-concept data will be generated using a rat contraceptive efficacy model and the well-established repeated, low dose SHIV challenge models using pigtail (intravaginal) and rhesus (intrarectal) macaques at CDC. Upon identification of the lead formulation, we will also draft a toxicology testing plan, clinical study design and clinical development plan to support a pre-IND meeting with the FDA (Specific Aim 5). Finally, in Specific Aim 6, we will build upon the formative work of SA3 with a discrete choice experiment to understand user and provider preferred product attributes for the LA MPT injectable, in order to refine the TPP and guide on-going product development efforts. In summary, this project proposes to develop, through preclinical proof-of-concept, a LA MPT injectable with a strong regulatory path for future clinical advancement, providing a significant advancement of a next-generation HIV prevention and contraceptive product that may fit into the lifestyles of at-risk women most in need.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2025 ( Subtotal = $0 )
2025	2023	OLD DOMINION UNIVERSITY	735 FAIRFAX AVE STE 909	NORFOLK	VA	23507	NORFOLK CITY	USA	Allergy and Infectious Diseases Research	001	5	2/24/2025	NON-COMPETING CONTINUATION	-$50,410
2025	2023	OLD DOMINION UNIVERSITY	HAMPTON BLVD	NORFOLK	VA	23529	NORFOLK CITY	USA	Allergy and Infectious Diseases Research	002	6	2/24/2025	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$381,450
2025	2023	OLD DOMINION UNIVERSITY	HAMPTON BLVD	NORFOLK	VA	23529	NORFOLK CITY	USA	Allergy and Infectious Diseases Research	003	6	3/24/2025	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$0
2025	2022	OLD DOMINION UNIVERSITY	735 FAIRFAX AVE STE 909	NORFOLK	VA	23507	NORFOLK CITY	USA	Allergy and Infectious Diseases Research	000	4	2/24/2025	EXTENSION WITH OR WITHOUT FUNDS	-$331,040
														Subtotal = $0

Issue Date FY: 2024 ( Subtotal = $0 )
2024	2023	EASTERN VIRGINIA MEDICAL SCHOOL	735 FAIRFAX AVE STE 909C	NORFOLK	VA	23507	NORFOLK CITY	USA	Allergy and Infectious Diseases Research	000	5	9/4/2024	NON-COMPETING CONTINUATION	-$1,986,389
2024	2023	OLD DOMINION UNIVERSITY	HAMPTON BLVD	NORFOLK	VA	23529	NORFOLK CITY	USA	Allergy and Infectious Diseases Research	001	6	9/4/2024	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$1,986,389
														Subtotal = $0

Issue Date FY: 2023 ( Subtotal = $3,176,070 )
2023	2023	EASTERN VIRGINIA MEDICAL SCHOOL	735 FAIRFAX AVE STE 909C	NORFOLK	VA	23507	NORFOLK CITY	USA	Allergy and Infectious Diseases Research	001	5	3/27/2023	NON-COMPETING CONTINUATION	$2,036,799
2023	2022	EASTERN VIRGINIA MEDICAL SCHOOL	735 FAIRFAX AVE STE 909C	NORFOLK	VA	23507	NORFOLK CITY	USA	Allergy and Infectious Diseases Research	000	4	2/15/2023	EXTENSION WITH OR WITHOUT FUNDS	$1,139,271
														Subtotal = $3,176,070

Issue Date FY: 2022 ( Subtotal = $2,012,571 )
2022	2022	EASTERN VIRGINIA MEDICAL SCHOOL	735 FAIRFAX AVE STE 909C	NORFOLK	VA	23507	NORFOLK CITY	USA	Allergy and Infectious Diseases Research	000	4	4/15/2022	EXTENSION WITH OR WITHOUT FUNDS	$2,012,571
														Subtotal = $2,012,571

Grand Total All Awards = $5,188,641

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Project Horizon: Hydrogel Injectable Depot System for Next-Generation Long-Acting HIV Prevention and Contraception

Award Number: R33AI142685

ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 02/01/2019

PERIOD OF PERFORMANCE END DATE: 03/31/2026

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